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. 2022 Oct 11;12(10):e055718. doi: 10.1136/bmjopen-2021-055718

Table 2.

Incidence of grade ≥3 AEs

System organ class
MedDRA preferred term
Danvatirsen monotherapy (cohort 1) N=5 Danvatirsen+durvalumab (cohort 2) N=6
Patients with any AE 3 (60.0) 6 (100.0)
Metabolism and nutrition disorders 2 (40.0) 1 (16.7)
 Hypermagnesaemia 1 (20.0) 0
 Hypertriglyceridaemia 0 1 (16.7)
 Hypokalaemia 1 (20.0) 0
Gastrointestinal disorders 1 (20.0) 0
 Pancreatitis 1 (20.0) 0
Hepatobiliary disorders 0 2 (33.3)
 Hepatic function abnormal (ALT/AST/γGT increased) 0 2 (33.3)
Investigations 1 (20.0) 3 (50.0)
 Neutrophil count decreased 0 2 (33.3)
 ALT increased 1 (20.0) 0
 AST increased 1 (20.0) 0
 Blood bilirubin increased 1 (20.0) 0
 γGT increased 1 (20.0) 1 (16.7)
 Platelet count decreased 0 1 (16.7)

Data are n (%).

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; γGT, gamma-glutamyl transferase.